AmplifyBio
Scaling Science for Life

In the early days of cell and gene therapy development, a large amount of drug safety data was generated. But CROs did not have a great grasp on product characterization or a detailed view of efficacy. The situation has changed today as there are more product approvals and an increasing number of patient indications going from the “rescue” trials to more mainstream. It has become essential for the CRO industry to be more precise and quantitative. It needs to use the myriad of data coming from the various next-generation of analytical instruments that have been developed over the last few years.

That’s where AmplifyBio is making a difference. The company is building preclinical CRO and product characterization capabilities that meet higher standards and help developers responsibly accelerate the delivery of novel therapeutics to the patients waiting for them.

“The most significant difference that AmplifyBio can make is by positioning and growing its capabilities to meet the expanding definition of drug safety that comes from a better understanding of the biology of advanced therapy mechanisms and the ability to fully characterize products,” says J. Kelly Ganjei, the CEO of AmplifyBio.

AmplifyBio partners with clients to provide a single preclinical study or full IND enabling programs with a strategic focus on developing advanced therapies. The company ensures excellence in the safety, efficacy, and toxicity testing from its world-class facility, which previously was part of Battelle. In addition, AmplifyBio’s clients have direct access to critical members of its team, including the executive team, study directors, project managers and scientific staff

AmplifyBio has implemented capabilities for agility, throughput, customization, and the various operating models that are necessary to support clients with more aggressive timelines. Whether it’s a modified animal model or perhaps a novel delivery/dose route, the company is now confident to quickly support all the requests.

Further, in the preclinical stage, lead times and efficient access to study data have been significant challenges. AmplifyBio has hired more than 100 new employees across scientific and management disciplines to eliminate human bottlenecks. It has also invested in high throughput platforms to increase agility, particularly in its pathology and analytics labs.

The new labs AmplifyBio has built at its headquarters in Columbus, Ohio, include digital PCR platforms, spectral cytometry, in-vivo imaging, improved immunological assay multiplexing ability, and automation in pathology, all aiming to execute studies on time and with the most amount of data possible. In the coming years, AmplifyBio will expand into a second site in New Albany, Ohio.

“We think a lot about our obligation to execute great science, and specifically how we will keep up with accurately and securely analysing and sharing that data. Since day 1, we’ve set out the mission to embrace being a data centric company,” states Ganjei.

As multiple technologies are becoming intertwined, AmplifyBio is investing in computing power and dynamic analysis platforms. That includes servers and lab computers with next-generation processors and ample storage for data analysis, which allows complex analysis of large datasets. To scale its footprint and harness data, AmplifyBio will be leveraging cloudbased computer storage in a compliant way. By having the right combination of information management systems with multiple types of computing options, the organization will have the ability to get through large data sets in a very short amount of time.